Absorbable Cranial Flap Fixation System
FDA 510(k) clearance K221606 · decided 2023-11-21
Clearance details
- K-number
- K221606
- Device name
- Absorbable Cranial Flap Fixation System
- Applicant
- Chendu Medart Medical Scientific Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-06-02
- Decision date
- 2023-11-21
- Days to decision
- 537 days
- Clearance type
- Traditional
- Product code
- GXR
- Device class
- 2
- Regulation number
- 882.5250
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Chengdu, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Chendu Medart Medical Scientific Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.